By Boudewijn Jong, SQA Associate, Netherlands Synopsis On 20 May 2020, the new European Union Medical Device Regulation (EU MDR) will go into effect. All Medical Devices manufactured and/or sold… read more →

Wins & Challenges It was a crazy summer for the McKay family. After dropping our son off at LAX to attend college overseas, my wife Carrie and I headed to… read more →

SQA Regulatory Surveillance Summary for Q2, 2019 International Council for Harmonization (ICH) Guidance ICH Harmonized Guideline, Optimization of Safety Data Collection, E19, Draft April 2019 This Guideline is intended to… read more →

Wins & Challenges Summer has started, along with some amazing scenery in California, since we’ve had periodic rain with a generous amount of sun. SQA has been evolving the past… read more →

Association for the Advancement of Medical Instrumentation (AAMI) AAMI News: Draft Guidance ‘Leapfrogs’ FDA into Regulation of Brain – Computer Interfaces, April 2019 For people affected by paralysis or an… read more →

Wins & Challenges Out here in Los Angeles, we’re used to summer weather starting around now, but I still find myself reaching for a jacket every morning. Despite our lack… read more →

European Federation for Cosmetic Ingredients (EFfCI) No updates noted for EFfCI Good Manufacturing Practice Working Group. Click here for more information    European Medicines Agency (EMA) Regulatory Science to 2025… read more →

China GMP WHO Statement on Rabies Vaccine Incident in China: 25 July 2018 The World Health Organization (WHO) fully supports the China National Drug Administration’s (CNDA’s) actions to withhold problematic… read more →

Wins & Challenges I usually end up writing these articles while flying. I find it peaceful, and for some reason being on a plane lets me open up my mind.… read more →

United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use… read more →